Back to resultsComparison of Biodentine and MTA Pulpotomies in the Primary Molar Teeth 3 Year Follow up
Primary Purpose
Pulpotomy, Dental Caries
Status
Completed
Phase
Early Phase 1
Locations
Turkey
Study Type
Interventional
Intervention
Biodentine
ProRoot (Aggregate)
Sponsored by
About this trial
This is an interventional treatment trial for Pulpotomy focused on measuring pulpotomy, pediatric dentistry, primary molars
Eligibility Criteria
Inclusion Criteria:
- no clinical and radiographic evidence of pulp pathology,
- no clinical and radiographic symptoms,
- no history of spontaneous pain and tenderness,
- no percussion, swelling or sinus tracts and pathologic mobility.
Exclusion Criteria:
- any clinical or radiographic evidence of pulp degeneration (spontaneous or nocturnal tooth pain, tenderness to percussion, pathological mobility, internal or external root resorption, swelling or fistula, widened periodontal ligament (PDL)
- furcal or periapical radiolucency teeth requiring more than 5 minutes to achieve hemostasis during clinical procedure.
- without permanent successor
Sites / Locations
- Istanbul University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Biodentine
ProRoot MTA
Arm Description
Dental materials
Dental Materials
Outcomes
Primary Outcome Measures
Total success rate
Secondary Outcome Measures
Total success rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03395496
Brief Title
Comparison of Biodentine and MTA Pulpotomies in the Primary Molar Teeth 3 Year Follow up
Official Title
Comparison of Biodentine and MTA Pulpotomies in the Primary Molar Teeth 3 Year Follow up
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
May 1, 2013 (Actual)
Primary Completion Date
May 1, 2016 (Actual)
Study Completion Date
May 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to compare two pulpotomy medicaments in primary molars clinically.A total of 200 primary molars with deep caries were treated with two different pulpotomy medicaments (Mineral Trioxide Aggregate and BiodentineTM) in this study. The inclusion criteria for tooth selection were no clinical and radiographic evidence of pulp pathology. During 36 months of follow-up at 3-month intervals, clinical and radiographic success and failures were recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulpotomy, Dental Caries
Keywords
pulpotomy, pediatric dentistry, primary molars
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biodentine
Arm Type
Experimental
Arm Description
Dental materials
Arm Title
ProRoot MTA
Arm Type
Experimental
Arm Description
Dental Materials
Intervention Type
Drug
Intervention Name(s)
Biodentine
Other Intervention Name(s)
77509635
Intervention Description
Biodentine pulpotomy agent
Intervention Type
Drug
Intervention Name(s)
ProRoot (Aggregate)
Other Intervention Name(s)
75896452
Intervention Description
ProRoot MTA pulpotomy agent
Primary Outcome Measure Information:
Title
Total success rate
Time Frame
12 months after pulpotomy treatment
Secondary Outcome Measure Information:
Title
Total success rate
Time Frame
24 months after pulpotomy treatment
Other Pre-specified Outcome Measures:
Title
Total success rate
Time Frame
36 months after pulpotomy treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
no clinical and radiographic evidence of pulp pathology,
no clinical and radiographic symptoms,
no history of spontaneous pain and tenderness,
no percussion, swelling or sinus tracts and pathologic mobility.
Exclusion Criteria:
any clinical or radiographic evidence of pulp degeneration (spontaneous or nocturnal tooth pain, tenderness to percussion, pathological mobility, internal or external root resorption, swelling or fistula, widened periodontal ligament (PDL)
furcal or periapical radiolucency teeth requiring more than 5 minutes to achieve hemostasis during clinical procedure.
without permanent successor
Facility Information:
Facility Name
Istanbul University
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Comparison of Biodentine and MTA Pulpotomies in the Primary Molar Teeth 3 Year Follow up
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